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Amicus Therapeutics (FOLD)
NASDAQ:FOLD

Amicus (FOLD) AI Stock Analysis

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Amicus

(NASDAQ:FOLD)

Rating:61Neutral
Price Target:
$6.00
▲(0.84%Upside)
The overall stock score is driven by positive earnings call outcomes and strategic collaborations, offset by financial instability and weak technical indicators. While revenue growth and strategic partnerships highlight future potential, current profitability challenges and technical downtrend limit the stock's immediate attractiveness.
Positive Factors
Market Position
FOLD shares are relatively attractive in the current environment which favors more advanced commercial biopharma companies.
Regulatory Opportunities
There has been a major push forward for additional regulatory flexibility in the FSGS indication, and it appears that FOLD wants to take advantage of this progress.
Negative Factors
Guidance Adjustment
Total revenue guidance for FY25 was lowered due to an unexpectedly higher UK VPAG rebate rate.
Sales Performance
Revenue for PomOp and Galafold missed expectations due to higher UK VPAG rebates.

Amicus (FOLD) vs. SPDR S&P 500 ETF (SPY)

Amicus Business Overview & Revenue Model

Company DescriptionAmicus Therapeutics, Inc., a biotechnology company, focuses on discovering, developing, and delivering medicines for rare diseases. Its commercial product and product candidates include Galafold, an oral precision medicine for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant based on in vitro assay data. It also develops AT-GAA, a novel treatment paradigm for Pompe disease; enzyme replacement therapies for Pompe diseases; CLN3, which is in Phase 1/2 clinical study to evaluate the safety and efficacy of a single intrathecal administration of an AAV serotype AT-GTX-502 gene therapy in patients with CLN3; and CDKL5, a gene on the X-chromosome encoding the CDKL5 protein that regulates the expression of essential proteins for normal brain development. The company has collaboration and license agreements with Nationwide Children's Hospital; University of Pennsylvania; and GlaxoSmithKline. Amicus Therapeutics, Inc. was incorporated in 2002 and is headquartered in Philadelphia, Pennsylvania.
How the Company Makes MoneyAmicus makes money through the development and commercialization of its pharmaceutical products, particularly targeting rare and orphan diseases. The company generates revenue primarily through product sales, especially from its flagship drug Galafold (migalastat), which is used to treat Fabry disease. Additionally, Amicus may also earn income from partnerships and collaborations with other pharmaceutical companies, which can include licensing agreements, milestone payments, and royalties. These strategic partnerships are significant contributors to its earnings, along with government grants or incentives for developing treatments for rare diseases.

Amicus Earnings Call Summary

Earnings Call Date:May 01, 2025
(Q1-2025)
|
% Change Since: -22.53%|
Next Earnings Date:Jul 31, 2025
Earnings Call Sentiment Positive
The call presented a strong positive outlook with significant growth in key areas such as revenue and strategic collaborations, alongside challenges including higher than expected rebates and revised revenue guidance. However, the highlights, particularly the strong growth and strategic partnerships, outweigh the lowlights, indicating positive sentiment.
Q1-2025 Updates
Positive Updates
Strong Double-Digit Revenue Growth
Amicus delivered its eleventh consecutive quarter of double-digit sales growth in its core business in Pompe and Fabry, with expectations for this trend to continue for years.
Strategic Collaboration with Dimerix
Amicus entered into a strategic collaboration with Dimerix, acquiring U.S. commercialization rights to DMX-200, a first-in-class compound in late Phase III development for a rare fatal kidney disease, with blockbuster market potential.
Onshoring Manufacturing to Strengthen Supply Chain
Amicus announced onshoring a portion of its drug product manufacturing to enhance its diversification strategy.
Galafold Revenue Growth and Market Share
Galafold revenue reached $104.2 million, up 6% at constant exchange rates, with a 14% increase in new patient starts and a 69% global market share of treated Fabry patients with amenable mutations.
Pombiliti and Opfolda Revenue Growth
Pombiliti and Opfolda revenue reached $21 million, up 92% at constant exchange rates, driven by significant growth in the U.S., Germany, and Spain.
Positive Outlook for DMX-200
The Phase III ACTION study for DMX-200 is progressing well, with FDA alignment on proteinuria as the primary endpoint for approval.
Negative Updates
Unexpected Rebate Impact in the UK
The UK's VPAG rebate was higher than anticipated, impacting revenue projections for both Galafold and Pombiliti and Opfolda.
Revised Revenue Guidance for Pombiliti and Opfolda
The full-year 2025 revenue growth guidance for Pombiliti and Opfolda was revised downwards from 65%-85% to 50%-65% at constant exchange rates.
Delayed Patient Starts in New Markets
Expected patient starts in newly reimbursed countries were delayed from Q1 to Q2, impacting immediate revenue projections.
Challenges with Nonlinear Order Patterns
Nonlinear order patterns outside the U.S. and unexpected factors impacted quarterly revenues for Galafold and Pom-Op.
Company Guidance
During the Amicus Therapeutics First Quarter 2025 Financial Results Conference Call, the company provided guidance that highlights several key metrics. The company reported a total revenue growth of 13% year-over-year, reaching $125.2 million, with a constant exchange rate growth of 15%. The revenue from Galafold reached $104.2 million, showing a 6% increase at constant exchange rates, while Pombiliti and Opfolda revenues increased by 92% to $21 million. Despite a higher-than-expected VPAG rebate in the UK impacting revenues, Amicus remains confident in achieving its full-year 2025 growth guidance for Galafold and revised its revenue growth guidance for Pombiliti and Opfolda to 50% to 65%. The company projects to reach combined sales of $1 billion by the end of 2028 for its two key products. Amicus also anticipates achieving GAAP profitability in the second half of 2025. The strategic collaboration with Dimerix and the expansion of their global supply chain further contribute to the company's positive outlook.

Amicus Financial Statement Overview

Summary
Amicus exhibits strong revenue growth and gross profit margins but faces challenges with persistent net losses and high debt levels, indicating financial instability. Cash flow metrics show improvement, but profitability and financial flexibility remain concerns.
Income Statement
65
Positive
The company shows a positive revenue growth trend with a TTM (Trailing-Twelve-Months) revenue of $543.1 million, up from $528.3 million in the previous annual period. Gross profit margin remains strong at approximately 91%. However, the net profit margin is negative due to consistent net losses, indicating profitability challenges. EBIT and EBITDA margins have improved but remain low, suggesting limited operational efficiency.
Balance Sheet
55
Neutral
The company's debt-to-equity ratio is relatively high, indicating significant leverage, which could pose a financial risk. The equity ratio stands at 24.5%, showing a moderate proportion of equity financing. The return on equity is negative due to net losses, highlighting the company's struggle to generate returns for shareholders.
Cash Flow
60
Neutral
The free cash flow has turned positive in the TTM period, showing improvement from the previous annual period. The operating cash flow to net income ratio is positive, indicating some level of cash generation from operations. However, the free cash flow to net income ratio remains low, pointing to challenges in converting earnings into cash flow.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue543.14M528.29M399.36M329.23M305.51M260.89M
Gross Profit494.22M475.35M362.03M290.63M271.05M229.84M
EBITDA53.63M29.39M-92.08M-199.58M-202.87M-242.98M
Net Income-29.37M-56.11M-151.58M-236.57M-250.46M-276.85M
Balance Sheet
Total Assets789.84M785.03M777.88M724.17M905.14M886.52M
Cash, Cash Equivalents and Short-Term Investments250.57M249.95M286.20M293.60M482.50M483.27M
Total Debt443.47M443.64M445.06M452.12M440.13M441.73M
Total Liabilities596.28M590.99M617.71M601.12M597.77M600.14M
Stockholders Equity193.56M194.04M160.17M123.05M307.37M286.38M
Cash Flow
Free Cash Flow1.61M-37.44M-76.53M-170.34M-206.38M-236.52M
Operating Cash Flow3.56M-33.89M-69.09M-166.57M-202.49M-233.29M
Investing Cash Flow-40.96M-560.00K98.06M92.32M78.76M-13.58M
Financing Cash Flow6.73M5.12M61.68M-7.46M212.07M262.86M

Amicus Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price5.95
Price Trends
50DMA
6.26
Negative
100DMA
7.39
Negative
200DMA
8.82
Negative
Market Momentum
MACD
-0.14
Negative
RSI
48.42
Neutral
STOCH
68.75
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For FOLD, the sentiment is Neutral. The current price of 5.95 is above the 20-day moving average (MA) of 5.91, below the 50-day MA of 6.26, and below the 200-day MA of 8.82, indicating a neutral trend. The MACD of -0.14 indicates Negative momentum. The RSI at 48.42 is Neutral, neither overbought nor oversold. The STOCH value of 68.75 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for FOLD.

Amicus Risk Analysis

Amicus disclosed 67 risk factors in its most recent earnings report. Amicus reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Amicus Peers Comparison

Overall Rating
UnderperformOutperform
Sector (63)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
63
Neutral
S$1.56B3.702.87%4.71%17.84%20.03%
61
Neutral
$1.80B-18.12%28.25%80.86%
58
Neutral
$3.43B-386.33%33.46%26.72%
53
Neutral
$2.25B-103.82%48.04%48.16%
51
Neutral
$2.66B-30.84%-1.20%
50
Neutral
$3.21B-106.71%-22.34%
45
Neutral
$2.76B-62.46%-43.10%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
FOLD
Amicus
5.95
-4.07
-40.62%
RARE
Ultragenyx Pharmaceutical
39.46
-1.42
-3.47%
APLS
Apellis Pharmaceuticals
17.82
-18.42
-50.83%
SRRK
Scholar Rock Holding
35.55
27.81
359.30%
CRNX
Crinetics Pharmaceuticals
29.44
-14.39
-32.83%
IMVT
Immunovant
16.81
-10.07
-37.46%

Amicus Corporate Events

Executive/Board ChangesShareholder Meetings
Amicus Stockholders Approve Directors and Equity Plan
Neutral
Jun 5, 2025

At the 2025 Annual Meeting of Stockholders held on June 5, 2025, Amicus‘s stockholders elected four Class III directors for a three-year term and approved the 2025 Equity Incentive Plan. They also ratified Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, and approved the executive compensation on an advisory basis.

The most recent analyst rating on (FOLD) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on Amicus stock, see the FOLD Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and Strategy
Amicus Secures License for DMX-200 Development
Positive
May 1, 2025

On April 30, 2025, Amicus Therapeutics entered into a license agreement with Dimerix Bioscience, granting Amicus exclusive rights to develop, manufacture, and commercialize Dimerix’s drug candidate DMX-200 in the United States for Focal Segmental Glomerulosclerosis (FSGS) and other indications. This agreement, effective May 1, 2025, includes a $30 million upfront payment and potential milestone payments totaling up to $560 million. Dimerix will continue funding the ongoing pivotal Phase 3 study for DMX-200, while Amicus will handle regulatory submissions and commercialization in the U.S. This collaboration aims to bring a transformative treatment to patients with FSGS, a rare kidney disease with limited treatment options, enhancing Amicus’s portfolio in the rare disease market.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jun 19, 2025